DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 1-14 and 16-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method for reducing or eliminating non-specific binding of polymer dye conjugate, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/24/2026.
Applicant's election with traverse of a composition (claims 22-29 and 31) in the reply filed on 6/24/2026 is acknowledged. The traversal is on the ground that Tantawy (US2015/0038397) fails to teach a fluorescent polymer dye according to formula (III). This is not found persuasive because presently cited Easwaran et al (WO2017180998) discloses such formula.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 22-29 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kurata et al (JP 2009139214) in view of Easwaran et al (WO2017180998, cited in IDS, cited herein with identical US 20190144601).
Kurata teaches a composition, where an oligomeric fluorescent dye solution is added to a latex, where pH is adjusted with ammonium hydroxide buffer at the presence of potassium laurate (see Preparation of polymer fine particle dispersion 13, meeting the limitations of claim 29).
Regarding claims 24 and 25, Kurata teaches that 0.3 g of potassium laurate is added to 140 g of the dispersion above.
Regarding claim 26, Kurata teaches a preservative, an antifungal agent, a pH adjuster, a viscosity adjuster, and the like can be added to the polymer fine particle dispersion of the present invention as necessary (see chapter Other additives).
Kurata discloses that Examples of the test substance as an antigen include biological hormones and drugs such as protein hormones, active peptides, autocoids, tumor markers, immunoglobulins, etc., which are present in minute amounts in the blood. There is no particular limitation as long as it can produce an antibody against the test substance.
Thus, Kurata teaches a polymeric dye, an anionic surfactant and a buffer.
However, the reference fails to teach the claimed formula of polymer dye conjugate.
Easwaran teaches water soluble photoactive macromolecular complexes and methods for detecting an analyte in a sample by using a binding agent conjugated to a water soluble photoactive macromolecule, where the water soluble fluorescent polymer having the structure of Formula I:
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896
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wherein each X is independently selected from the group consisting of a C and Si;
each Y is independently selected from the group consisting of a bond, CR1R2, and SiR1R2;
when Y is a bond X is directly bonded to both rings;
each R1 is independently selected from the group consisting of polyethylene glycol (PEG), ammonium alkyl salt, ammonium alkyloxy salt, ammonium oligoether salt, sulfonate alkyl salt, sulfonate alkoxy salt, sulfonate oligoether salt, sulfonamido oligoether, and
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328
210
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each R2 is independently selected from the group consisting of H, alkyl, alkene, alkyne, cycloalkyl, haloalkyl, alkoxy, (hetero)aryloxy, aryl, (hetero)arylamino, a PEG group, ammonium alkyl salt, ammonium alkyloxy salt, ammonium oligoether salt, sulfonate alkyl salt, sulfonate alkoxy salt, sulfonate oligoether salt, sulfonamido oligoether, and
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each R3 is independently selected from the group consisting of H, alkyl, alkene, alkyne, cycloalkyl, haloalkyl, alkoxy, (hetero)aryloxy, aryl, (hetero)arylamino, and a PEG group;
each Z is independently selected from the group consisting of C, O, and N;
each Q is independently selected from the group consisting of a bond, NH, NR4, and CH2; (see Abstract and claim 1).
Note that similar to Kurata’s composition, Easwaran’s one is used for such target analytes as polypeptides, proteins, lipids and specific markers (see 0144), meeting the limitations of claim 23.
Easwaran discloses that the flow cytometric analysis of lysed whole blood stained with the new polymers-labeled anti-human CD4 and Pacific Blue-labeled CD4 was undertaken. The positive signal intensity of polymer dyes were nearly 5 times higher than Pacific Blue ( see FIG. 3 and Example 6 at 0163).
Therefore, it would have been obvious to a person of ordinary skills in the art before the effective filing date of the invention to use Easwaran’s water soluble fluorescent polymer in Kuroda’s composition, since it provides much higher sensitivity in biological assays.
In reference to claim 27, Easwaran fails to teach reduced non-specific binding to white cells.
However, The claiming of a new use, new function or unknown property, which is inherently present in the prior art, does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, it would have been obvious to a person of ordinary skills in the art before the effective filing date of the invention to expect the same properties from Applicant’s and modified Kuroda’s compositions, since they have the same formula.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY LISTVOYB whose telephone number is (571)272-6105. The examiner can normally be reached 9am-5pm EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heidi Riviere Kelley can be reached at (571) 270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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GL
/GREGORY LISTVOYB/Primary Examiner, Art Unit 1765
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